FDA 510(k) Application Details - K970629

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K970629
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SUNTECH MEDICAL INSTRUMENTS, INC. 8917 GLENWOOD AVE. RALEIGH, NC 27617 US Other 510(k) Applications for this Company
Contact	DAVID GALLICK Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/1997
Decision Date	01/02/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review